Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP.

SOPs require a lot of explanation: What are the basics? How many are enough? How many are too many? Who creates them? Who monitors them? How do we train them? How often do we train them? How do we document that training? Where should SOPs live? Should they be controlled documents, or is a Note to File sufficient? All of these questions leave many of us overwhelmed and wondering what to do.

So we procrastinate, we ignore, and we find other projects that are much more rewarding. But the SOP can be a very powerful tool. To begin, all it takes is understanding the purpose of the SOP. From there we can write it, train it, follow it, and update it regularly. When done well, we will have robust SOPs that will serve us for a very long time. However, many fall short of fulfilling the directives they should provide. As a result, we hear chatter within the industry that we really don’t need SOPs or that too many SOPs kill productivity. But both the FDA and Office of Human Research Protections (OHRP) have published expectations of what they should find during an inspection.

This hands-on workshop will de-mystify writing Standard Operating Procedures, and will focus on how to create a well written SOP that will provide continuous support and value to its users. Participants will be provided with guidelines and templates that ensure that new and updated SOPs are uniform and user friendly.

Review case scenarios: FDA Warning Letters with interactions of SOP options that could have prevented the Warning Letter

Using tools to help conduct an assessment of needed SOPs

Review each element of a well-written SOP including the modification log, purpose, scope, responsibilities, and general procedures

Applied practice skills with hands-on creation of an SOP

Creating the SOP index

How to document SOP training: Best practices,who and how often

How to maintain the SOP

$800 by Early Bird Deadline noted in Upcoming Courses section above

$1,000 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training. All participants are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 6 hours (0.6 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-14-048-L01-P. Released: 2/14.

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.